Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Extra notes in the data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Reason
Use of unapproved drugs with synchromed pumps can result in an increased risk of permanent motor stall and cessation of drug infusion.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Extra notes in the data
Report Source: NCAR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Reason
As a result of this software issue, these devices may display incorrect information on the
remaining doses available in the device to the user (e.G., the device may display that
three doses remain in the cartridge when less than three actually remain).
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Extra notes in the data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Reason
Interference from triglycerides occurs at a level lower than what is stated in the package insert.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Extra notes in the data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Reason
Mobius imaging believes, due to an issue with the configuration settings of the tilt-drive motion controller, if a tilt-drive motor has an intermittent connection or broken encoder or sensor wire there is a risk of unintended tilt motion of gantry while airo system is homing the axis at startup or preparing for a scan.
since the airo is not currently monitoring for intermittent connections or broken tilt-drive motor wires, if a wire breaks or the signal becomes intermittent the tilt-drive motor would not get the correct feedback and the motor could behave unpredictably.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Extra notes in the data
Report Source: NCAR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Reason
Molnlycke health care has identified an error with the label of the insert card of the above referenced procedure pak trays. the information on the label incorrectly states ''does not contain latex''. there are components within these trays which do contain latex. the label should advise that the tray does contain latex.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Extra notes in the data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Reason
An issue has been brought to the attention of synergy health (uk) ltd from the field regarding the detachments of the tape intended to be securely stitched to the corner of "swab gauze xrd 30x30 18ply". the root cause has been determined to be components within the final product were past their expiry.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Extra notes in the data
Report Source: NCAR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Reason
Software anomaly may cause pump shutdown, which render the device inoperable until a recovery process is performed.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Extra notes in the data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Reason
A hazardous situation may be created when mounting these monitors using the 75mm vesa mounting hole pattern provided in the battery cover of these monitors.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Extra notes in the data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Reason
Packaging of the filter may become damaged during transportation under extreme conditions.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Extra notes in the data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Reason
National biological corporation has received reports indicating that certain hand foot ii (model uvb-138) devices may have been shipped with a timer that doesn't function correctly. if the lamps turn on when the key is turned on the device is wired incorrectly.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Extra notes in the data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Extra notes in the data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Reason
1- small number of instances where the olymoic cool-cap systems control module has experienced a frozen screen during the treatment of infants.
2- small number of instances where the power supply within the cooling module of the olympic cool-cap system has faield.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Extra notes in the data
Report Source: NCAR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Reason
Newdeal sas has recently become aware that one batch of snap-off® screw dia. 2.7mm- length 20mm non sterile (catalog number 117 020 – batch ek79) has been etched and labeled with specifications of the snap-off® screw dia. 3.0mm length 20mm sterile (catalog number 117 120s – batch en5j).
although we have not received any information showing that the use of such affected devices had significant consequence on patients, as a preventive measure, newdeal sas has made a decision to conduct a recall.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Extra notes in the data
Report Source: NCAR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Reason
Newdeal sas has recently become aware that certain screws of one batch of surfix® alpha screw diameter 2.7mm (catalog number 295214s – batch egh9) have been etched and labeled with (length): inadequate specifications some 12 mm long screws are etched with reference and batch corresponding to 14mm long screws.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Extra notes in the data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company
Reason
A fault in the lock plate of the cart, some lock plate are not thick enough to support the monitor under condition of frequent tilting. in a worst-case situation, the monitor can fall over.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Extra notes in the data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Reason
Nobel biocare quality management systems observed an issue with a material used in the packaging of their implants. their internal analysis has confirmed that this material is not according to their standards.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Extra notes in the data
Report Source: NCAR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Reason
The meter may generate consecutive error codes for multiple samples from the same patient, which may mask abnormal glucose levels.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Extra notes in the data
Report Source: NCAR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Reason
Investigation by the manufacturer showed that in the service mode the “source alignment procedure” could be started with the door physically open. the door interlock only triggers if the door is closed prior to alignment. the alignment can also be done with the doorswitch on linac . if set to linac , the door interlock to the hdr will always be seen by flexitron as being open. in the source alignment mode of the flexitron, the firmware does not look at the state of the door interlock but only to the state-change ( from closed to open). in this case the ir192 –source was thus not automatically retracted into the vault of the apparatus when opening the door of the irradiation bunker as the door switch only works in clinical mode.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Extra notes in the data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Reason
Incorrect source step size may occur in oncentra brachy plans for ring or venezia applicator models with microselectron.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Extra notes in the data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company
Reason
Ohio medical corporation had one complaint regarding a screw used to attach one of the feet of the unit. if the screw is over tightened, it may potentially damage the battery inside the device.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Extra notes in the data
Report Source: NCAR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Reason
Dqbl*03:05:02 and dqbl*03:05:04 can possibly give wrong result due to the false negative in
primermix 11. dqbl*03:05:01 and dqbl*03:05:03 reacts as they should.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Extra notes in the data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Reason
The manufacturer of the shockpulse generator, cybersonics inc, produced the product in accordance with iec60601-1 standard, with an independent laboratory successfully certifying the system. however, more recent testing has identified that under certain conditions one of the test criteria (touch current under single fault condition) has the potential to exceed the standard.
Data from Singapore is current through September 2018. All of the data comes from the Health Sciences Authority (HSA), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Singapore.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Extra notes in the data
Report Source: NCAR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Reason
The manufacturer has identified that in some cases the outer needle of double lumen needles can become detached from the handle during oocyte retrieval and also the outer needle can be twisted around the inner needle. this can lead to an increase in discomfort including more bleeding than normal for the patient during the procedure.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Extra notes in the data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Reason
Potential for positively biased results using vitros® chemistry products na+ slides.